INFUSE Bone Grafts and Spinal Surgery
Millions of Americans suffer back pain from degenerative disk disease and other conditions for which they receive physical therapy, pain medication and, in some cases, spinal surgery.
Medtronic, a medical device manufacturer, promoted and sold the INFUSE bone graft product for the purpose of strengthening the lower spine by fusing two adjacent vertebrae together. INFUSE (bone morphogenetic protein-2) stimulates bone growth in the space between vertebrae. It is used in place of the patient's own bone in spinal fusion surgery.
In 2002, the U.S. Food and Drug Administration (FDA) approved INFUSE for only one type of spine surgery: anterior approach lumbar interbody fusion (ALIF). In this surgery, the surgeon operates on the spine through an incision in the abdomen.
INFUSE was not approved (and still is not approved) for other types of spinal surgeries, such as posterior-approach lumbar interbody fusion surgeries (where the surgeon operates through the back). Likewise, the FDA has not approved INFUSE for spinal surgery involving the upper back and neck (the cervical spine).
Why is INFUSE bone graft used only for this one type of surgery?
Early testing of other types of surgical procedures showed the potential for serious medical complications. In 1999, a Medtronic-sponsored clinical trial of posterior lumbar interbody fusion indicated that bone was forming in the wrong place in 70 percent of the patients participating in the study. Clinical trials were stopped after only 34 surgeries had taken place.
However, the market for back pain surgery is extensive and by 2007 the INFUSE bone graft product was being used for back surgeries for which it had not been approved, including cervical spinal fusions. Our investigation has revealed that such use was caused, in part, by the aggressive off label promotion of the product by Medtronic.
Dangerous side effects began to appear in more and more bone graft patients. Some complications, such as bone overgrowth, were clearly connected to INFUSE. Other side effects were not as immediately identifiable.
If you have suffered medical problems because of the way an INFUSE bone graft was used, talk to a medical specialist who is knowledgeable about the latest findings on the INFUSE product.
Know Your Legal Rights When it Comes to Defective Medical Devices
If you are one of the many patients to suffer side effects after having back surgery, it's important that you understand your legal rights. Contact a California product liability lawyer online or call toll free 800.811.3649.
The San Francisco law firm of Walkup, Melodia, Kelly & Schoenberger represents people who have been injured by defective medical devices and dangerous drugs. Our firm has a long track record of successful financial recovery for injured people in California, Nevada and across the U.S.
Your consultation is FREE. If our defective medical device attorney believes you may have a case, we will obtain a medical review of your records to determine if you are eligible to bring a defective product claim for injuries from an INFUSE bone graft.